Substance Use Disorder, Brain and Behavioral Regulation

Brain and Behavioral Regulation Processes in a Population With Substance Use Disorder

The proposed project seeks to explore the effects of a neuroregulation paradigm named Z-Score Quantitative Electroencephalogram (QEEG) guided sLORETA neurofeedback (ZQLN) on optimizing brain electrophysiological activity and behavioral performance in a substance use disorder (SUD) population whose primary drug of use is cocaine.

Study Overview

• Status: Withdrawn
• Conditions: Substance Use Disorders
• Intervention / Treatment: Device: QEEG-Guided sLoreta Neurofeedback Training

Detailed Description

Aim 1. Measure the effects of ZQLN training on brain electrophysiological activation changes in SUD patients. QEEG and Event-Related Potentials procedures, recorded with a 19-channel digital EEG, will be conducted before and after 12-15 sessions of ZQLN to examine changes on dysregulated brain sites by inspection of the brain maps deviating brain areas sLORETA Brodmann Areas Voxels Z-Scores inside and outside the target window of -/+2 standard deviations. Observation of P300 component latencies and amplitudes will be measured during a Drug-cue GoNoGo paradigm.

Aim 2. Measure the effects of ZQLN training on behavioral performance changes in SUD patients. In the same participants of Aim 1, Pre and Post behavioral performance (before and after 12-15 sessions of ZQLN) includes the assessment of attention and executive function, episodic memory, working memory language, and processing speed as measured by the NIH Toolbox Cognitive Domains battery scales. Other behavioral variables include reaction times, omission, and commission errors in the Drug-cue GoNoGo task.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Puerto Rico
  • PR
    • San Juan, PR, Puerto Rico, 00935
      • Administración de Servicios de Salud Mental y Contra la Adicción. Centro Residencial de Mujeres y Varones

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion criteria

• Age limit: 21 to 51
• Cocaine as a primary drug of selection
• Be stable (such as not having reading or movement problems preventing them from using a computer keyboard or iPad).
• Have completed the first stage of treatment in the program (this first phase consists of the stabilization and detoxification period of the program participants)

Exclusion criteria

• History of brain injury.
• Previous experience with neurofeedback training.
• Being unavailable to complete assessments.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: QEEG-guided sLoreta Neurofeedback; Brainmaster Discovery 24 EEG amplifier and BrainAvatar software will be used to conduct the neurofeedback sessions

Device: QEEG-Guided sLoreta Neurofeedback Training; The team will produce a neurofeedback (NFB) protocol based on QEEG sLORETA Brodmann Voxel evaluation of brain deviated/dysregulated areas. Subsequent 12 to15 sessions of individualized NFB protocol will be conducted using BrainAvatar software to normalize these regions. The NFB session will display the cortical surface and subsurface networks being trained in a live fashion. Patients will be seated on a comfortable chair in a dimly lit room and, wearing a 19-channel EEG-cap connected to an EEG amplifier, they will receive auditory and visual feedback when they meet Brodmann Voxels Z-Scores inside of +/-1.5 standard deviations (SD) on each electrode training site. Thresholds for the feedback will be first set a +/-2 SD and brought down to +/-1.5 SD throughout the sessions (subject performance dependent). Patients are encouraged to relax, hear the sounds, and watch a feedback game.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
sLORETA Brodmann Areas Voxels Z-Scores	An increase of the percent of sLORETA Brodmann Areas Voxels Z-Scores inside the target window of -/+2 standard deviations after a series of ZQLN sessions is expected.	2 months
Event-Related Potentials P300 latencies	Brain response P300 component average latencies (measured in milliseconds) Drug-cue GoNoGo task.	2 months
Event-Related Potentials P300 amplitudes Drug-cue Go	Brain response P300 component average amplitudes (measured in microvolts) during Drug-cue GoNoGo. task.	2 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Attentional Executive Functioning NIH Toolbox Task	Flanker Inhibitory Control and Attention Task. The allocation of one's limited capacities to deal with abundance of environmental stimulation (duration 3 minutes)	2 months
Episodic Memory NIH Toolbox Task	Picture Sequence Memory Task. Cognitive processes involved in the acquisition, storage and retrieval of new information. (7 minutes duration)	2 months
Working Memory NIH Toolbox Task	List Sorting Working Memory Task. The ability to store information until the amount of information to be stored exceeds one's capacity to hold that information. (7 minutes duration)	2 months
Executive Function NIH Toolbox Task	Dimensional Change Card Sort Task. The capacity to plan, organize, and monitor the executive of behaviors that are strategically directed in a goal-oriented manner. (4 minutes duration)	2 months
Processing Speed NIH Toolbox Task	Pattern Comparison Processing Speed Test. Assesses the amount of information that can be processed within a certain unit of time. Items are simple so as to purely measure processing speed. (3 minute duration)	2 months
Drug-cue Go Task Reaction Times	Average Reaction times (measured in milliseconds) to the Go stimulus. In the first block of the task the Go stimulus will be a neutral category (animal or household) and in the second block the Go stimulus will be the drug-related picture.	2 months
Drug-cue Go Task Omission Errors	Average frequency of omission errors (not responding to the Go stimulus). In the first block of the task the Go stimulus will be a neutral category (animal or household) and in the second block the Go stimulus will be the drug-related picture.	2 months
Drug-cue NoGo Task Commission Errors	Average frequency of commission errors (responding to the NoGo stimulus). In the first block of the task the Go stimulus will be a neutral category (animal or household) and in the second block the Go stimulus will be the drug-related picture.	2 months

Collaborators and Investigators

• Sponsor: University of Puerto Rico
• Investigators: Principal Investigator: Ismael Castillo Reyes, PhD, University of Puerto Rico

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2025
• Primary Completion (Estimated): March 31, 2026
• Study Completion (Estimated): May 30, 2026

Study Registration Dates

• First Submitted: March 27, 2023
• First Submitted That Met QC Criteria: June 15, 2023
• First Posted (Actual): June 20, 2023

Study Record Updates

• Last Update Posted (Estimated): October 10, 2025
• Last Update Submitted That Met QC Criteria: October 8, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders
• Other Study ID Numbers: PuertoRico

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Data and findings will be published in peer-review health sciences journals and presented at national and international scientific conferences, especially those related to Neurotherapy, cognitive neuroscience, and biological psychiatry. Findings and insights gained from this study will be shared with government agencies, and medical institutions that provide services for neuro and psychiatric patients, both in Puerto Rico and in the U.S. General Data, without personal identifiers, will be made available to other researchers in Puerto Rico and other institutions outside the country for secondary analyses in their areas of expertise, or confirmation of the adequacy of our findings and conclusions. The research resources developed during the proposed project will be readily available for research purposes to qualified individuals within the scientific community to advance further research in this field. Findings will also be shared via newspapers, news releases, and press conferences.
• IPD Sharing Time Frame: Data will be available for one year after the study completion.
• IPD Sharing Access Criteria: Email to ismael.castillo@upr.edu
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No